← Back to Search

CAR T-cell Therapy

CAR-T Therapy for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Led By John Baird, M.D.

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the first 12 months follow up period completion (3 years)

Awards & highlights

Study Summary

This trial is testing a new CAR-T therapy that targets two proteins found on B-cells to treat adults with B-cell non-Hodgkin lymphoma who have relapsed or are refractory to other treatments.

Who is the study for?

Adults with B-Cell non-Hodgkin lymphoma that has come back or didn't respond after at least two standard treatments can join. They must be over 18, have a certain level of physical fitness (ECOG status 0 or 1), and their major organs need to function well. People with recent serious blood clots, active severe infections, other cancers within the last five years (except some skin or in situ cancers), pregnant women, and those with certain heart conditions cannot participate.Check my eligibility

What is being tested?

The trial is testing JNJ-90014496, an experimental CAR T-cell therapy targeting CD19 and CD20 proteins on cancer cells. It's for adults whose aggressive B-cell non-Hodgkin lymphoma hasn't been cured by previous treatments. This Phase Ib study is open-label, meaning everyone knows they're getting the test treatment.See study design

What are the potential side effects?

Potential side effects may include immune system reactions causing inflammation in various body parts, infusion-related symptoms like fever or chills, fatigue, digestive issues such as nausea or diarrhea, blood cell count changes increasing infection risk; specific side effect profiles will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My tumor is confirmed to be CD19 or CD20 positive.

Select...

I am 18 years old or older.

Select...

I have been diagnosed with a type of aggressive large B cell lymphoma or follicular lymphoma.

Select...

My disease has come back or hasn't responded to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the first 12 months follow up period completion (3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the first 12 months follow up period completion (3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the first 12 months follow up period completion (3 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of the Recommended Phase 2 Dose (RP2D) of JNJ-90014496 in Participants with Relapsed or Refractory B-cell non-Hodgkin lymphoma (B-NHL)

Occurrence of Adverse Events (AEs) [Safety and Tolerability]

Secondary outcome measures

Duration of Response (DOR)

Overall Response (OR)

Pharmacokinetic Evaluation of JNJ-90014496

+1 more

Other outcome measures

Anti-drug (C-CAR039) antibody

Blood cytokines changes

Overall survival (OS)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: JNJ-90014496Experimental Treatment1 Intervention

Participants will receive intravenous (IV) infusion of autologous JNJ-90014496 on Day 1.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,384,588 Total Patients Enrolled

Cellular Biomedicine Group Ltd.Lead Sponsor

31 Previous Clinical Trials

1,474 Total Patients Enrolled

Cellular Biomedicine Group, Inc.Lead Sponsor

2 Previous Clinical Trials

112 Total Patients Enrolled

Media Library

C-CAR039 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05421663 — Phase 1

B-Cell Non-Hodgkin Lymphoma Research Study Groups: JNJ-90014496

B-Cell Non-Hodgkin Lymphoma Clinical Trial 2023: C-CAR039 Highlights & Side Effects. Trial Name: NCT05421663 — Phase 1

C-CAR039 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05421663 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaging in this clinical experiment?

"Affirmative. Clinicaltrials.gov's information reveals that this clinical trial, first advertised on August 9th 2022, is still enrolling patients. The study aims to enrol 15 people from a single medical centre."

Answered by AI

Does this clinical experiment currently have an open enrollment period?

"Correct. According to the information found on clinicaltrials.gov, this medical trial started recruiting participants from August 9th 2022 and is still actively doing so. The research requires 15 people at a single site to be enrolled in order for it to succeed."

Answered by AI

Has the FDA authorized CD19/CD20-directed CAR-T cells to be utilized by medical professionals?

"Our research team judged the safety of CD19/CD20-directed CAR-T cells to be a 1 due to being in Phase 1, which means there is only preliminary data that supports its efficacy and limited information regarding its safety."

Answered by AI

What outcomes is this study aiming to manifest?

"This clinical trial's primary outcome, tracked over a 12-month time frame, will be the incidence of Adverse Events [Safety and Tolerability]. Secondary objectives include monitoring C-CAR039 CAR copy number in peripheral blood with qPCR, measuring maximal plasma concentration of C-CAR039 in peripheral blood (Cmax), and estimating overall response rate by determining both complete response (CR) rate and partial response (PR) rates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

2022. "A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05421663.